Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

National Center for Cardiovascular Diseases

Status and phase: Enrolling; Phase 4

Conditions: Calcium-Phosphorus Metabolism Disorders; Chronic Kidney Disease(CKD); Degenerative Heart Valve Disease; Heart Valve Calcification

Treatments: Drug: Sevelamer; Drug: Calcium carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT06660524

2023-GSP-GG-38

Details and patient eligibility

About

The goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD). The main questions it aims to answer are:

• Does Sevelamer lower the progression of heart valve calcification compared to calcium carbonate over 12 months?
• What are the impacts of calcium-phosphorus regulation therapy on major cardiovascular events such as heart failure, cardiovascular death, and the need for valve surgery? Researchers will compare Sevelamer to calcium carbonate to see if Sevelamer is more effective in reducing heart valve calcification.

Participants will:

• Take Sevelamer or calcium carbonate daily for 12 months.
• Undergo echocardiography and CT scans at baseline and after 12 months to assess heart valve calcification.
• Attend follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed.

Enrollment: 196 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 50 years old.

  • Degenerative valvular heart disease clearly diagnosed by ultrasound or clinical history with calcification manifestation (including no stenosis or insufficiency due to calcification, mild, moderate and severe stenosis and insufficiency caused by calcification).

    • Glomerular filtration rate < 60 mL/min (CKD-EPI formula).

      • Serum phosphorus > 1.45 mmol/L (4.5 mg/dl).

Exclusion criteria

• Patients refuse to sign the informed consent form for the study.

  • Non-degenerative valvular heart disease even if there is valvular calcification, such as rheumatic valvular heart disease, congenital valvular heart disease, etc.

    • Valve lesions are evaluated by cardiac surgeons and have indications for surgical thoracotomy or interventional medical treatment and there are no surgical contraindications.

      • Life expectancy less than 1 year. ⑤ Abnormal parathyroid function.

        • Those with renal insufficiency who are planned to undergo dialysis treatment within half a year.

          • Malignant tumor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Sevelamer Treatment

Experimental group

Description:

Sevelamer is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guideline for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.

Treatment:

Drug: Sevelamer

Calcium Carbonate Treatment

Active Comparator group

Description:

Calcium carbonate is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guideline for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.

Treatment:

Drug: Calcium carbonate